Journal of Medical Cases, ISSN 1923-4155 print, 1923-4163 online, Open Access
Article copyright, the authors; Journal compilation copyright, J Med Cases and Elmer Press Inc
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Case Report

Volume 5, Number 11, November 2014, pages 603-609

Case Series of Cancer Patients Treated With Galunisertib, a Transforming Growth Factor-Beta Receptor I Kinase Inhibitor in a First-in-Human Dose Study


Figure 1.
Figure 1. Computer tomography (CT) and positron emission tomography (PET) images of a patient (R15) with a co-primary tumor of the rectum (bottom two rows) with lung metastasis (top two rows). This patient was inadvertently enrolled in the study and retrospective evaluation showed a PET lesion in the rectal mucosa at baseline (green circle). A CT and PET scan also showed a lesion in the lung, which became gradually larger during the treatment with galunisertib (verified with CT scan).
Figure 2.
Figure 2. Section of the aorta in a patient (R23) treated with galunisertib. From the patient’s aorta different areas were stained with H&E staining and Alcian Blue (left two panels) and silver staining (right two panels).
Figure 3.
Figure 3. Thrombocytopenia in two patients (R35 and R73) treated with galunisertib. Both patients received prior bevacizumab and showed a reduction in platelet counts. However, both also showed a significant reduction in platelet counts after starting on galunisertib.


Table 1. Patients With Important Responses and Adverse Events Observations in FHD Study
Patient IDDiagnosis (WHO grade for glioma)Main adverse event
Part A (galunisertib monotherapy)
  R30Astrocytoma grade IIIDiarrhea CTC grade 2
  R12GlioblastomaThromboembolic event
  R15GlioblastomaCo-primary tumor of the gut
  R23GlioblastomaThromboembolic event
  R28Astrocytoma grade IIIStroke after re-resection
  R35GlioblastomaThrombocytopenia CTC grade 4
Part B (galunisertib + lomustine)
  R56GlioblastomaSalmonella infection
  R63GlioblastomaListeria infection
Part C (galunisertib monotherapy)
  R66GlioblastomaLegionella infection
Fungal infection
Herpes infection
  R67GlioblastomaE. coli infection
  R73GlioblastomaThrombocytopenia CTC grade 3